Associate Director, Site Contract and Budget Management in Remote at Daiichi Sankyo

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThe Site Contracts and Budget Management (SCBM) group develops strategy and provides oversight to all studies in compliance with internal processes and external requirements for the following areas in the study start up space - Site Contracts, Budgets and Site Payment processes. The current process is supported by CRO partners and the SCBM group is required to build an effective collaboration with our strategic alliance partnership and a process for appropriate oversight of any outsourced or contracted activities utilizing both performance and quality measurements.

The Associate Director, SCBM position provides leadership in strategy and process development to ensure the implementation of best practices in the timely and efficient delivery of site contracts. As a Subject Matter Expert (SME) for the site contract and budget processes, the role develops portfolio level site contract and budget strategy, oversees the escalation process, identifies process improvements, participates in functional governance activities and CRO relationship management, and liaises with internal/external stakeholders on cross-functional initiatives with particular focus on study start-up.

Business needs within the group may require this role to take on an increased focus on one or more of the above areas or even additional related areas to ensure Global Clinical Operations (GCO) goals are met.

Responsibilities

• SME Site Contracts and Budgets
  The role will provide subject matter expertise, guidance and execution support to the GCO functions
  This role will liaise with the various functions in GCO and outside GCO (Legal, Compliance) and provide functional input to develop better defined process flows, roles and responsibilities, and templates to ensure smooth transitions and handoffs are maintained with rigorous oversight
  Liaise with Legal, Compliance on company positions on legal developments and regulatory guidances
  Collaborate with the appropriate stakeholders within and outside of GCO including but not limited to GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Corporate Compliance, Clinical Development, Global Project Management, and Functional Quality groups, to ensure site contract and budget processes and expectations are mutually well understood
  Overseeing the global site payment process
  The role will provide guidance and support to the execution function when needed to ensure timely and compliant resolution of site contract and budget issues
  Provide guidance and support for the Site Budget development process
  Managing issues, risks and challenges in the fair market value evaluation of site budget escalations
  Oversee the financial reconciliation process for Site Budgets
  Respond to CRO queries on DSI financial policies impacting investigator fees
  Collaborate with the Regional Engagement Site Management (RESM) team on the resolution of site financial issues
  Serving as a point of contact to address site contract related payment and tax-related matters in collaboration with relevant DS stakeholders (e.g. corporate tax team)
• Performance Management, Oversight

  Provide effective CRO performance management and oversight by establishing and monitoring performance and quality metrics and processes for strategic partnerships
  Ensure that an effective escalation framework for site contracting and budgets & CRO operational performance issues exists
  Participate and provide input at appropriate functional oversight bodies
  Support and drive relationship management and optimization efforts
  Provide support on GCO and non-GCO process improvement initiatives
  Define/Update/Refine operating models to meet evolving business needs
  Provide resource management through forecasting and work-flow management

• Process Documentation and Process Improvement

  Participate in technology initiatives to support efficiencies
  Support build of Standard Operating Procedures and Instructions and ensure they are current and documented per quality documentation requirements and DSI process management standards
  Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization
  Lead identification and implementation of improvements to the site contract and budget processes
  Work cross-functionally with stakeholders to identify when a process revision is required

• Quality Program Support

  Provide expert guidance on the standards and areas of internal and external compliance
  Design, implement a quality oversight plan for site contracts and budget
  Provide oversight to ensure (i) the establishment of key checks and balances and (ii) a monitoring plan to ensure a state of inspection readiness throughout the life of the clinical program & study (key clinical study areas include but not limited to maintenance of study eTMF and subcontracting tracking)
  Establish, maintain and provide training and guidance to other supportive roles to ensure full compliance with processes and requirements

• People Management & Resource Planning
  Support development of a plan for resourcing of activities within remit/scope
  Depending on business priorities, manage employee direct reports and associated employee development duties
  Depending on business priorities, manage contractor-based staff in collaboration with DSI HR and vendor providers as appropriate

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• Bachelor's Degree preferred
• Master's Degree Or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities for this position. preferred

Experience Qualifications

• Minimum 8-9 years pharmaceutical / biotechnology industry experience. required
• Demonstrated success in working cross-functionally in a global matrix organization; minimum 5 years’ experience in managing or supporting global cross-functional processes. required
• Must have previous experience with Site Contract and Budget Management and held a leadership position in driving processes and oversight. required
• Must have previous experience with Site Contracts and budget management. required
• Must have experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines. required
• Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills. required
• Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe. required
• Proven networking skills and ability to share knowledge and experience amongst colleagues. required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.